Public advisory

Unauthorized health products from Kausch International Goods may pose serious health risks

Last updated

Summary

Product
Unauthorized health product labelled to contain a prescription drug
Issue
Health products - Product safety
What to do

Do not use these products. Return them to your local pharmacy for proper disposal. Consult a health care professional if you have used any of these products and have health concerns. Prescription drugs can only be legally sold with a prescription. Buy your prescription drugs from licensed pharmacies only.

Affected products

Product Promoted use Health risk
Brilliant Skin Essentials Brilliant Rejuv Set Skin lightening Labelled to contain hydroquinone and tretinoin
Brilliant Skin Essentials Brilliant Rejuv Topical Cream Skin lightening Labelled to contain hydroquinone and tretinoin
Brilliant Skin Essentials
Topical Solution (Toner)
Skin lightening Labelled to contain hydroquinone and tretinoin
Brilliant Skin Essentials Rejuvenating Facial Toner Skin lightening Product with similar packaging (previously removed from sale) was tested and found to contain tretinoin
Solmux carbocisteine 100mg/5mL Pediatric Syrup Mucolytic (thins mucus) Labelled to contain carbocisteine
Solmux carbocisteine 200mg/5mL Pediatric Syrup Mucolytic (thins mucus) Labelled to contain carbocisteine
Solmux carbocisteine Forte 500mg/5mL Adult Suspension Mucolytic (thins mucus) Labelled to contain carbocisteine

Issue

Health Canada is warning consumers about unauthorized health products that it removed from sale from Kausch International Goods’ online Facebook store and its associated warehouse in Calgary, AB. The unauthorized products were labelled or previously tested and found to contain prescription drugs and may pose serious health risks.

Selling unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives or contaminants that may or may not be listed on the label. These ingredients could interact with other medications and foods. In addition, these products may not actually contain the active ingredients that consumers would expect them to contain to help maintain and improve their health.

Prescription drugs should only be used under the advice and supervision of a health care professional because they are used to treat specific conditions and may cause serious side effects.

What you should do

  • Do not use these products. Return the product to your local pharmacy for proper disposal.
  • Consult a health care professional if you have used any of these products and have health concerns.
  • Buy your prescription drugs only from licensed pharmacies.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Background

Carbocisteine is a prescription drug that is not approved for use in Canada. It is used in other countries to treat conditions associated with too much mucus in the respiratory tract. Side effects include diarrhea, nausea and heartburn. Serious allergic (e.g., anaphylactic) and skin reactions have been reported with its use. Carbocisteine can disrupt the lining of the stomach and can cause gastrointestinal bleeding in the elderly, those with a history of peptic ulcers, or patients taking medications known to cause gastrointestinal bleeds such as acetylsalicylic acid (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs). The use of carbocisteine by pregnant people is not recommended.

Hydroquinone is a prescription drug when it is greater than a 2% concentration and a natural health product at a concentration of 2% and under. It is used topically (applied to the skin) to lighten areas of darkened skin caused by different conditions (e.g., sun exposure, skin damage, pregnancy, medications or age). It should not be used by people who are allergic to hydroquinone or who are taking medicines that make their skin more sensitive to light. Hydroquinone is not recommended for pregnant or breastfeeding people, or for children. It should be used with caution in those who have previously had cancer. Side effects include skin reactions such as redness, dryness, cracked skin, burning, stinging, peeling, itching, increased sensitivity to sunlight, sunburn, blisters and scarring. It may cause skin discolouration (i.e., blue or black discolouration or white patches or spots) that, in some cases, can be disfiguring. In laboratory animals, it has been associated with cancer after long-term exposure.

Tretinoin in topical format (applied to the skin) is a prescription drug used to treat acne. Topical tretinoin should not be used during pregnancy as it has been associated with birth defects. It should also not be used by those who are breastfeeding or by children under 12 years old, or by individuals who have inflamed or irritated skin, have a previous skin cancer or undiagnosed skin lesions, who are taking medicines that make their skin more sensitive to light, or who have an allergy to tretinoin. Tretinoin may cause pain, irritation, itchiness, redness, or swelling at the site of application. It may damage skin, change skin colour, and increase sensitivity to sunlight or tanning beds, causing sunburns. Using tretinoin in combination with hydroquinone may increase some of the side effects of tretinoin.

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
Identification number
RA-73060
Media and public enquiries

Media Enquiries:
Health Canada

(613) 957-2983

media@hc-sc.gc.ca

Public Enquiries:
(613) 957-2991

1-866 225-0709

info@hc-sc.gc.ca